Recall Z-0843-2022 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Howmedica Osteonics Corp.
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
| Date | Jan 14, 2022 |
| Status | Open, Classified |
| Reason | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall (UMDR) PFA 2902313 on 14th January 2022 to affected consignees. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. |
| Quantity | 39 units Updated: 40 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium. ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052718 | V40 BIOLOX DELTA CERAMIC FEMORAL HEADS Howmedica Osteonics Corp., Oct 27, 2005 |